SC-018-135

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<h2>Indications, Safety, and Warnings</h2> <h4>For combined Trailblazer Support and Trailblazer Angled Support Catheters</h4> <p><b>Important information:</b> : Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.</p> <h3>TrailBlazer™ Support / TrailBlazer™ Angled Support Catheters</h3> <p><b>Indications for use:</b> TrailBlazer™ support/TrailBlazer™ angled support catheters are percutaneous, single lumen catheters designed for use in the peripheral vascular system. TrailBlazer/TrailBlazer angled support catheters are intended to guide and support a guidewire during access of the vasculature, to allow for wire exchanges, and to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.</p> <p><b>Potential adverse events: </b>The following complications may result, but may not be limited to the following conditions: Access site complications, Arterial dissections, Arterial spasms, Arterial thrombosis, Catheter fracture with tip separation and distal embolization, Death, Distal Embolization (air, blood clots, or plaque), Intimal disruption, Local or systemic infection including sepsis, Perforation and vessel rupture, and Surgical Intervention. </p> <p><b>Caution:</b> Federal law (United States) restricts these devices to sale by or on the order of a physician.</p> <p>FTSOP113326-67d</p>

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